Abstract
BackgroundOver one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial.Methods/designMixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face Vs postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial.DiscussionTo our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial.Trial registrationThe trial is registered ISRCTN Number 38581822.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-015-0017-z) contains supplementary material, which is available to authorized users.
Highlights
Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work
Whilst study heterogeneity and known difficulty in following people with traumatic brain injury (TBI) up over time [12] explain some of the difference in reported TBI work outcomes, inadequate rehabilitation cannot be excluded as a cause
In a single-centre cohort comparison, an early TBI specialist vocational rehabilitation intervention (ESTVR) delivered by an occupational therapist (OT), supported by a TBI case manager was compared to usual National Health Service (NHS) rehabilitation and found it to be more effective (27 % more people with moderate and severe TBI in work at 12 months) at returning people with TBI to work and keeping them there 12 months after injury than usual care [26]
Summary
Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. The societal cost of TBI in terms of diagnostic tests, treatment, rehabilitation, lost time at work and dependency on benefits is estimated at 2.8 billion Euros per year in Germany (price year unclear but survey conducted 2000/1) [3]. It is a known cause of personal bankruptcy [4]. Many TBI survivors return prematurely but leave once the impact of the brain injury on their job is realized [13]
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